Bioprospecting and Deep-Sea Genetic Resources in a Fragmenting International Law

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Bioprospecting and

Deep-Sea Genetic Resources

in a Fragmenting International Law

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Juridiska institutionens skriftserie

School of Business, Economics and Law at University of Gothenburg Skrift 038

2021

Bioprospecting and Deep-sea Genetic Resources in a Fragmenting International Law © Niels Krabbe 2021

Cover: Illustration by Signe Hagerman Print: Stema specialtryck AB, Borås ISBN 978-91-8009-376-7 (Print) ISBN 978-91-8009-377-4 (PDF)

Abstract

This thesis investigates if public international law manages to function as a coherent system in the case of deep-sea bioprospecting, where rules in three regimes provide seemingly inconsistent obligations for states.

Based on an investigation of the development of bioprospecting and patenting of deep-sea genetic resources, the study explores how rules in the United Nations Convention on the Law of the Sea (UNCLOS), the Convention on Biological Diversity (CBD) and the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO TRIPS) apply to such activities. It is illustrated how rules of these treaties provide different and seemingly inconsistent obligations for states in the context of deep-sea bioprospecting. This is explained by their origin in different regimes of public international law with distinctively dissimilar perspectives on the appropriation of genetic resources.

It is discussed how the prima facie norm conflict in some cases can be resolved on the basis of the principles on treaty application and interpretation under the Vienna Convention on the Law of Treaties. In other cases, such as the obligations for bioprospecting of deep-seabed micro-organisms, states are faced with an irreconcilable dilemma; the different treaty obligations cannot be simultaneously applied. In order to prevent such conflicts and ensure the credibility of international law as a functioning system, new approaches are suggested, in particular the development of holistic conflict clauses and lex

specialis. The case of deep-sea bioprospecting calls for a more state-oriented

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For my mother, Margrethe Krabbe (1948 - 2017), who taught me the joy of learning and the love of all living things

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There is a pleasure in the pathless woods, There is a rapture on the lonely shore, There is society where none intrudes, By the deep sea, and music in its roar: I love not Man the less, but Nature more, From these our interviews, in which I steal From all I may be, or have been before, To mingle with the Universe, and feel

What I can ne'er express, yet cannot all conceal.

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Acknowledgements

The research presented in this thesis was funded by an employment as a doctoral candidate at the Department of Law of the University of Gothenburg. I am most grateful for having been offered this opportunity. Over the past five years my research has benefited greatly from stimulating exchanges with colleagues from different strands of legal scholarship. I’d like to thank all my colleagues at the department, in particular those involved in the Ocean Governance Law Group, which represents a truly inspiring academic setting. The research could not have been produced without the numerous friends and colleagues who have provided inspiration and advice throughout this project. I am particularly indebted to my supervisors Professors David Langlet and Ulf Petrusson.

Over the years I have had the pleasure to discuss my thoughts, and learn from, legal scholars, judges, negotiators, government officials and my students. I owe a great debt to all of them, including those that do not appear here explicitly by name. My research has also benefited greatly from discussions with scholars in other disciplines. Colleagues in different fields of marine sciences have enthusiastically introduced me to the strange world of the ocean depths. I have learnt about the connections between organisms, technology and application from biotechnologists and geneticists.

I would like to thank Professors Gregor Noll, Mikael Baaz and Ulf Linderfalk, as well as Matilda Arvidsson and Hannes Lenk for acting as opponents at my doctoral seminars. I would also like to thank all participants in the doctoral retreats Critical Research in International Law 2017 and 2018, organized by Professor Pål Wrange at the Stockholm Centre for International Law and Justice. Professors Anne Orford, David Kennedy and Rosemary Rayfuse provided particularly helpful external advice on the direction of this project.

I am also most grateful to those who inspired and encouraged me to venture into research, including Professor Harry N. Schreiber at UC Berkeley as well as Judges Tomas Heidar and Rüdiger Wolfrum at the Rhodes Academy of Oceans Law and Policy. I am equally indebted to my high school teacher Rolf Wendin at Schillerska gymnasiet, who opened the door to social sciences. On a more personal note, I have thoroughly enjoyed sharing joys and hardships with Aron Westholm and Patrik Emblad. To me, our common office has served as a monastery of friendship and wisdom. I would also like to thank Gabriela Argüello, Elin Sandegård, Kristina Hultegård, Kristina Wejstål, David Jivegård, Jhonnie Kern, Jonas Kyrönviita and all other doctoral student colleagues. My good friend Signe Hagerman has kindly provided graphic design and artwork.

Lastly, I would never have set out on this course without the support of my family. I was born into a warm and loving home where culture, nature, learning and discussion were held in high esteem. I remain forever grateful for these gifts from my mother and father. My sister, brothers and my extended family in Denmark and Sweden has also been a great source of inspiration and comfort. Most of all, my wife Cecilia, the rock of our family and my high school sweetheart has carried me through this project.

Niels Krabbe

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Preface

This study comprises an analysis of the rules in international law applicable to deep-sea bioprospecting. These rules, which concern access to, protection of, and patentability of deep-sea biological resources are found in three distinct regimes of international law. To what extent these rules are compatible or can possibly be made compatible through the use of established methods of application and interpretation of international law is the central theme of the study. In this way, it is a case study on fragmentation of international law and the ability of the system’s internal mechanisms to overcome apparent inconsistencies in allegedly hard cases like deep-sea bioprospecting.

For deep-sea bioprospecting, international law provides inconsistent rules, originating from distinct regimes characterized by distinct logics and underlying objectives. This puts states in a paradoxical situation; it is impossible to implement one obligation without violating another. Rules of treaty application and interpretation are unable to fully dissolve this problem. Such cases of catch 22 of international law connect to an increasing systemic fragmentation into different regimes. As is shown in the case of deep-sea bioprospecting, regimes are based on different objectives and logics. When rules from several regimes apply in parallel there is a risk for norm conflicts. This dysfunctionality and the resulting lack of credibility challenges the legitimacy of international law as a coherent system. It puts states in a situation where their only option is to implement international law selectively, by means of norm shopping. It also increases the risk for powerful states to dominate the system, by circumventing a prohibitive rule in one treaty by reference to a permissive rule in another. The dilemma of norm conflict may be prevented, it is suggested, by increasing institutional cooperation and consideration of rules across treaty boundaries as well as the development of holistic conflict clauses and lex specialis. This is particularly relevant in the marine sphere, where different uses, activities and their implications transcend boundaries and a broad range of treaties provide different and partly overlapping obligations. Nowhere else is it more acute than in areas beyond national jurisdiction, where different commons-principles and lack of exclusive state rights provide special legal conditions.

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A. Approaching deep-sea bioprospecting and

international law

A.1. Introductory remarks

A commercial enterprise commissions a marine research vessel and sails to the Mid-Atlantic, well beyond the maritime zones of Atlantic coastal states. There, a submarine vessel is sent down to harvest samples of organisms in an extremophile tubeworm community situated at a hydrothermal vent, ecosystems where organisms display functions which have not been identified elsewhere on the planet. On board the research vessel, the DNA of a retrieved micro-organism is sequenced. In subsequent clinical trials on land, a protein discovered during sequestration is demonstrated to have tumor-inhibiting properties. A patent application is filed, with prospects for the development of a commercially lucrative pharmaceutical drug.

Under US interpretation, not only of its own treaty obligations, but of the implication of international law in general, there is nothing preventing such operations or the enterprise from applying for and being granted a patent, provided that the discovery meets standard requirements. In the view of Argentina, by contrast, the actual bioprospecting mission would be unlawful without an express permit from the International Seabed Authority. Moreover, the findings would have to be shared universally. Any application for or granting of patents or other exclusive rights based on the finding would amount to illegal appropriation of a global resource belonging to all of humanity. The European Union would consider it in line with international law to conduct the mission, provided that the conservation of the relevant ecosystem is not endangered, and much like the US, the EU would grant patent for the invention. They may, however, suggest that international law rules require that the benefits from the finding should somehow be shared.

How can the different legal perspective across states be explained, considering that they are based on the same rules of international law? The diverging views on deep-sea bioprospecting, which also are reflected in domestic law, are the result of different understandings among states of what obligations apply to deep-sea bioprospecting.

In this study, the rules of international law applying to such activities will be examined. The study will explore how, as a result of fragmentation, different regimes of international law have developed seemingly inconsistent obligations to the same activity and how deep-sea bioprospecting should be considered under treaty law. Deep-sea bioprospecting thus presents states with a legal dilemma. In order to understand the challenges this new activity represents for international law, a closer look at characteristics of deep-sea bioprospecting is required.

A.2. Why investigate the legal status of deep-sea

bioprospecting under international law?

A.2.1. A difficult case under international law

The status under international law of the deep sea and its resources as global commons beyond national jurisdiction raises legal challenges to the bioprospecting of genetic resources in these areas. Moreover, different sub-fields of international law provide potentially conflicting obligations relating to such activities. States are both required to enable and prevented from allowing the appropriation of genetic resources from these areas for private purposes, as well as obliged to ensure their conservation.

The law of the sea has been developed based on a rigid division between sci-entific research and resource extraction as well as a narrow conception of how marine resources can and should be exploited, reflecting human use and scien-tific knowledge of the 1970 and 80s, when central provisions in the United Nations Convention on the Law of the Sea (UNCLOS)1_{were negotiated. Yet} these rules have a general scope of application, which in important regards encompasses deep-sea bioprospecting. The deep-sea areas of the oceans largely overlap with the areas which under the law of the sea are considered beyond national jurisdiction. These are divided into two distinctive legal com-mons-concepts: The High Seas includes the water column beyond the limits of the maritime zones of coastal states. The Area encompasses the seafloor and underlying sediments beyond the continental shelf of coastal states.

1_{The United Nations Convention on the Law of the Sea, signed in Montego Bay, Jamaica 10}

December 1982 and became effective 16 November 1994, 1833 U.N.T.S. 397 (UNCLOS) (United Nations ed., United Nations 1997).

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The two zones differ considerably as legal concepts, but have important elements in common. Both the rules on the High Seas and the Area are based on the notion that no state is entitled to assert sovereignty over these areas, and resources contained in these parts of the oceans are generally regarded as global commons. However, the legal implications differ considerably between the two zones. The commons regime of the High seas is essentially one of open-access, enabling appropriation of living organisms by all states and private actors as the main rule. The commons regime of the Area, on the other hand, is built on the principle of common heritage of mankind, which implies that appropriation in the form of resource extraction, as well as scientific research, only can be undertaken for the benefit of mankind, as opposed to state or private interest. Indeed, under the law of the sea, no actor is granted access unless complex procedures and requirements have been fulfilled.

In contrast to this restrictive approach to appropriation of deep-sea genetic resources, WTO-law has a more permissive perspective. According to the standard rule, states should grant patents for biotechnological inventions originating in deep-sea organisms provided that patent criteria are fulfilled. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)2_{provides no exception from the obligation to enable claims for} exclusive rights to biotechnological inventions originating in deep-sea organisms.

On the contrary, states are prevented from excluding the types of organisms which appear to be most relevant in bioprospecting from patentability. States are thus not merely free to accept claims for legal rights connected to genetic functions of deep-sea organisms: They are required to ensure the protection of private claims for exclusive rights by means of patenting for the types of organisms which include the most commercially relevant bioresources.

2_{Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 15 April 1994,}

Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299 (WTO TRIPS).

International environmental law represents a third approach to the appropriation of deep-sea resources. Much of the rules of the Convention on Biological Diversity (CBD)3_{are geographically confined to coastal waters,} where an advanced system for safeguarding national sovereignty over genetic resources applies. No restrictions are raised in relation to the appropriation of deep-sea genetic resources per se. It does, however, provide obligations to share results, not to cause damage to ecosystems, as well as duties to cooperate for the conservation and sustainable use of biodiversity in their natural habitats. Bioprospecting and the genetic resources of deep-sea organisms thus represent an example of how different areas of international law can provide obligations relating to the same activity in a multitude of different and, potentially conflicting ways. Generally, depending on what area of international law is used as perspective, the legal status of organisms and the use of their genetic resources would be interpreted differently. As a result, across different areas of international law, rules are provided for distinct aspects of the appropriation of organisms and their genomes. This goes for terrestrial as well as marine life, but it is most striking and arguably most relevant on the marine side, where the limitations on state sovereignty are manifold and the legal status of the major part of the oceans as global commons highlights dissimilar perspectives. These differences between sub-areas of international law, in this study referred to as regimes, raise a multitude of questions: How do obligations across different regimes apply to deep-sea bioprospecting? What underlying reasons might explain why rules diverge? How does international law handle cases of potentially overlapping and conflicting norms? Can it be established what rules should be given priority?

In this study, the emphasis is on how international law applies to deep-sea bioprospecting, and how inconsistency between obligations relating to such activities could be explained and understood under treaty law rules. The interest of investigating this problem is further supported by extra-legal aspects of deep-sea bioprospecting.

3_{The Convention on Biological Diversity, regarding the conservation of biodiversity, the}

sustainable use of its components and the fair and equitable sharing of the benefits arising thereof, signed at the Earth Summit in Rio de Janeiro, Brazil, in 1992 and entered into force on 29 December 1993, 1760 U.N.T.S. 69 (CBD).

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A.2.2. Growing interest in marine bioprospecting

The seemingly inconsistent rules for deep-sea bioprospecting in international law is not just a theoretical problem. Indeed, the organisms of the deep sea are emerging from the dark abyssal plains and mid-ocean ridges and their instrumental value in biotechnology development is becoming increasingly apparent. Technology and practical procedures relating to deep-sea bioprospecting have undergone dramatic changes in recent years. Genetic sequencing and engineering have opened new possibilities. Increased cooperation has blurred the lines between research and commercial development. The commercial potential of deep-sea genetic resources is closely connected to the challenges that the elements raise for the survival of all organisms in these parts of the biosphere. In order to withstand the extreme conditions in the deep sea, life has developed its most peculiar forms, with properties that cannot be found anywhere else. The prospects of using these functions in commercial development has been propelled by decreased costs in sequencing and submersible vehicles. The increasing commercial interests, technological development and the unique biological conditions of the deep sea and its organisms makes it evident that there are also practical arguments for investigating the legal status of bioprospecting under international law. Interest in deep-sea bioprospecting is indeed soaring. Discoveries in marine organisms are increasingly being patented for pharmaceutical purposes.4 Already by 2007, more than 15,000 molecules from marine genetic resources had been isolated and described.5_{Such bioactive compounds with} anti-inflammatory, anti-carcinogenic or anti-tumor functions, or those with the potential to treat HIV/AIDS are already being used in the biotechnology, biopharmaceutical and cosmetics industries.6_{Since 1999, the number of} patents originating from marine genetic resources has increased on average 12 per cent each year, which is more than 10 times faster than the rate of

4_{David Leary, et al., Marine genetic resources: A review of scientific and commercial interest,}

33 MARINE POLICY (2009).

5_{Sybille Van den Hove & Vincent Moreau, Deep-sea biodiversity and ecosystems: a scoping}

report on their socio-economy, management and governance (2007).

6_{Salvatore Arico & Charlotte Salpin, Bioprospecting of Genetic Resources in the Deep Seabed:}

Scientific, Legal and Policy Aspects § 20 (United Nations University, Institute of Advance Studies. 2005).

description of marine species.7_{The increased activity in marine bioprospecting} is mainly due to two factors.

Firstly, rapid technological innovation enables a more cost-effective and economically viable exploration of the genetic diversity of the oceans. This includes not only marine equipment such as submersible vehicles. As will be discussed in Part B, an even more significant factor has been the remarkable development and lowering costs relating to laboratory technology, including genetic sequencing and engineering. This laboratory development has not just propelled marine biotechnology; the increased interest in marine genetic resources is part of a generally growing interest in bio-based innovation, which aside from technological factors can also be explained by the move away from synthetic-based drug development. The genetic sequencing revolution in the 1990s prompted the pharmaceutical sector to abandon bio-based innovation and turn to large-scale sampling of synthetic compounds. The increasing realization in recent years that not even large-scale testing of synthetic samples can compensate for the developmental shortcuts enabled by the evolution of natural organisms has resulted in a resurgence of interest in bioprospecting. Secondly, in bioprospecting generally, operations target areas and species with a high likelihood of providing new and useful properties. Two interests are considered central in this regard: the diversity and novelty of genetic resources. This explains why the bioprospecting trend is particularly pronounced in relation to marine organisms. The microbial and prokaryote gene richness found in the oceans is expected to be orders of magnitude greater than the rest of the biosphere.8_{Moreover, life in the seas remains largely unexplored.} Studies indicate that bioprospecting of a marine species is twice as likely to result in a patent, compared to a terrestrial species. Today there are 18,000 products with their origins in marine organisms belonging to 4,800 named species.9_{The number of such products increases by about 4 per cent annually.}10

7_{Jesús M. Arrieta, et al., What Lies Underneath: Conserving the Oceans’ Genetic Resources,}

107 PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES (2010).

8_V_{AN DEN}_H_OVE_& _M_OREAU_{. 2007; Richard J. McLaughlin, Exploiting Marine Genetic}

Resources beyond National Jurisdiction and the International Protection of Intellectual Property

Rights: Can They Coexist?, in LAW, TECHNOLOGY AND SCIENCE FOR OCEANS IN GLOBALISATION:

IUU FISHING, OIL POLLUTION, BIOPROSPECTING, OUTER CONTINENTAL SHELF (Davor Vidas ed.

2010).

9_{Arrieta, et al., Proceedings of the National Academy of Sciences (2010).}

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This development has not gone unnoticed in the political and economic sphere. The economic potential of blue biotechnology has been identified as one of the main areas in the EU Maritime Strategy. The European Commission is expecting substantial growth in the sector.11_{As a consequence, the EU has} allocated considerable resources for research initiatives in the marine bioprospecting field.12

A.2.3. The genetic resources of the ocean deeps

Why, then, is the legal regime for bioprospecting in the deep seas chosen as the subject for the present study instead of the rules applying to such activities in coastal waters? The first reason is connected to the legal status of the deep seas, as discussed above. The second reason relates to the nature of life in the deep sea. If genetic diversity and the likelihood of finding novel and useful properties is generally higher among marine than terrestrial species, these elements are particularly prominent in deep-sea species.

The marine areas beyond national jurisdiction, of which the largest parts are deep seas, comprise two thirds of the total surface of the world’s oceans and constitute four fifths of all marine waters measured in volume. Yet these parts of the oceans were long believed to be biological deserts.

11_{Blue growth has been the EU long term strategy for promoting sustainable growth in the}

marine and maritime sector. This has been the maritime contribution to the realization of the Europe 2020 strategy for smart, sustainable and inclusive growth, Communication from the Commission on Blue Growth – Opportunities for marine and maritime sustainable growth. (2012). See, for a specific explanation of the EU’s marine biotechnology sector and thereto connected research, Green Paper on Maritime Policy [COM(2006) 275]: European Commission Background paper No. 10 on Marine Biotechnology (2006) as well as comprehensive

information provided at the Commission Blue Biotechnology portal

https://ec.europa.eu/maritimeaffairs/policy/biotechnology (site accessed November 30, 2020).

12_{Several research projects have been granted considerable contributions. For instance, Pharma}

Sea was during 2013 granted an EU financing amounting to over 9.5 million euros. The project

focuses on bioprospecting and the development and commercialization of new bioactive substances from marine organisms, including deep sea sponges and bacteria, in order to investigate their potential for application in pharmaceuticals, nutrition or cosmetics (see: http://www.pharma-sea.eu/). The connecting project MaCuMBA was 2012 granted an EU financing of 9 million euros (see: http://www.macumbaproject.eu/) (sites accessed November 30, 2020).

Although the deep sea is still less explored than the surface of Mars, recent exploration and research has put paid to the idea that the deep sea is a lifeless zone. Expeditions conducted during the past two decades have established that life is not only abundant in the deep sea, but more diverse and endemic than in most places in the biosphere. It has been estimated that between 500,000 and 100 million species live in the deep-sea portions of the world’s oceans.13_For example, as much as ten per cent of the total living biomass on Earth exists as oceanic subsurface bacteria, most of it unidentified.14_{Similarly, the deep} seafloor beneath the open ocean has a topography which is comparable in complexity to the terrestrial environment and hosts an abundant variety of organisms.15

The high seas conceal some of the world’s most exceptional species and extraordinary habitats.16_{To a large degree, this can be explained by the} conditions for life in the deep seas, which are among the most challenging of the entire biosphere. In order to exist in these areas, organisms have developed abilities to withstand immense pressure and complete darkness. As a result, life exhibits its most extreme forms in the deep sea. Indeed, the challenges for life in these environments has made evolution take turns not seen in other environments. One well-known example of this is the extremophiles living in the proximity of deep-sea vents at mid-ocean ridges which have developed unique properties. These include not only the ability to withstand extreme temperatures and pressures, but also complete independence from photosynthesis. Instead, some of these organisms depend on the sulfur cycle. If the sun turned out from one day to the next, these organisms would be completely unaffected. Another, less visually documented example is the dark biosphere, an entire ecosystem living without light or oxygen, flourishing beneath the ocean floor. Similarly based on chemosynthesis, it is potentially one of the planet’s biggest ecosystems.

13_{While about three-quarters of the Earth is covered by water, only as little as 5% of the ocean}

has been systematically explored for life, JESSE H.AUSUBEL, et al.,FIRST CENSUS OF MARINE

LIFE 2010:HIGHLIGHTS OF A DECADE OF DISCOVERY (2010).

14_{McLaughlin. 2010.}

15_{Robin Warner, Protecting the Oceans beyond National Jurisdiction: Strengthening the}

International Law Framework § Legal Aspects of Sustainable Development Series, No. 3, xxiv (2009), at 2-3.

16_{Roberto Danovaro, et al., Challenging the paradigms of deep-sea ecology, 29 T}_{RENDS IN}

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This high degree of genetic diversity and prevalence of useful functions, which is the result of deep-sea conditions, substantially increases the likelihood of valuable bioprospecting findings.

The prospects for deep-sea bioprospecting are further amplified by the lack of previous exploration. Areas beyond national jurisdiction, the vast majority of which are in the deep sea, represent the largest environments on the planet, yet they are also the least understood.17_{This world, beyond the jurisdiction of} states, is largely unexplored. The ratio of new discoveries in the deep ocean is 1:1 for each of the samples taken.18_{The overwhelming majority of deep-sea} species remain undiscovered and are yet to be described.19_{It is thus not} surprising that the commercial interest in and potential for genetic exploration of deep-sea organisms is high and rising.

A.3. Approaching deep-sea bioprospecting in light of

international law

Examining the legal status of deep-sea bioprospecting under international law is thus relevant not only because of the implications of the legal problem, but also considering the increasing commercial interest and scientific and technological aspects. In relation to international law, three elements of deep-sea bioprospecting appear particularly contentious.

A.3.1 Role of natural compound

In bioprospecting generally, the species origin and quantity of genes is less commercially relevant than the potential function of bioactive properties. Genetic diversity and lack of previous exploration are guiding indicators in targeting areas and ecosystems. Relevant samples may be retrieved from

deep-17_{Eva Ramirez-Llodra, et al., Deep, diverse and definitely different: unique attributes of the}

world's largest ecosystem, 7 BIOGEOSCIENCES (2010).

18_{Salvatore Arico, Marine Genetic Resources in Areas beyond National Jurisdiction and}

Intellectual Property Rights, in LAW, TECHNOLOGY AND SCIENCE FOR OCEANS IN GLOBALISATION:

IUU FISHING, OIL POLLUTION, BIOPROSPECTING, OUTER CONTINENTAL SHELF (Davor Vidas ed.

2010).

19_{While about three-quarters of the Earth is covered by water, only as little as 5% of the ocean}

has been systematically explored for life, AUSUBEL, et al. 2010.

sea bacteria, fungus, fish or any other type of marine organism. In most cases, only the collection of a limited compound of biological material is required. Bioprospecting thereby challenges the basic premise of international law rules for management of living resources of the seas. Largely, these rules focus on the harvesting of living resources for food consumption and have been developed with the purpose of maintaining a maximum catch of major stocks of larger fish species. Such traditional marine living resource extraction – fisheries – collects numerous individuals of the same species in bulk, which are then with a few intermediate steps sold as commercial products. Commercial prospects in fisheries thus essentially depend on quantity, and little consideration is paid to genetic diversity or bioactive properties beyond the quality of the flesh. Accordingly, the rules which have been developed for managing such activities are almost exclusively concerned with the interest of commercial fisheries and are based on the character of such activities. Yet the obligations have a general character and a broad scope of application, encompassing all utilization of marine living resources. This represents a considerable legal challenge for marine bioprospecting; such activities fall within and must comply with rules which have been developed for fundamentally different uses of marine organisms.

Moreover, in bioprospecting generally, the prospect for making novel discoveries of bioactive properties with potential for human use is the central guiding criterion in sampling operations. Species with these characteristics occur most frequently in the endemic ecosystems where even limited operations may have a detrimental environmental impact. In these areas, international environmental law rules also provide obligations on in situ conservation. In such cases, the objectives of the rules may be incompatible with the interest of bioprospecting.

A.3.2. Process aspects

Moreover, the bioprospecting process, as it has developed, and the different steps it involves lead to a range of additional challenges in relation to applicable rules of international law. The most burdensome and costly phases of bioprospecting development – and most relevant discoveries – are regularly performed after the relevant marine sample has been collected, in laboratories on land.

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As will be discussed in Part B, it is increasingly common that the different steps of the bioprospecting process (such as physical sampling, identification of promising properties, patenting and product development) are conducted by different entities. It appears that in many cases, the entity conducting the physical sampling is not even aware that the compound may subsequently be used in the development of biotechnology products. Conversely, commercial actors often find it easier to access sample collections stored in research collections such as sample libraries or sequence data, than to engage in costly sampling operations. Yet the emphasis in applicable rules in international law is put on physical activities in the marine environment. Moreover, fundamentally different obligations are provided for resource extraction and scientific research. There is thus a discrepancy between the nature of marine bioprospecting processes and the rules applying to the activities involved.

A.3.3. Gene technology and the role of the physical natural

element

Challenges in relation to international law are also posed by the implications of technology and methods employed in contemporary biotechnology. The natural genetic exploration in bioprospecting, as it is carried out today, regularly consists of only a minor collection of a genetic component which performs or has the potential to perform a useful function. Commonly in a laboratory environment, the active compound is then identified by DNA sequencing. According to the standard formula, the molecule performing the relevant function is subsequently patented and manufactured synthetically. Eventually, a commercial product is developed. In such cases, no physical component from the marine organism is used in the relevant product. Arguably, in this model, the genetic function of the natural organism merely serves as a source of inspiration for a function used in a product.

Does this lack of physical natural ingredient in the final product render international law rules on the use of natural resources inapplicable? Or is the connection to a natural genetic resource sufficient for regarding the full process, including the relevant function and the final product, as covered by such rules? It may be claimed that it is irrelevant whether any natural physical material is used directly; the origin of the active compound is what matters when deciding whether the product should be considered as containing genetic material with an origin in nature.

In any event, it is clear that even if the organism is not used in direct physical terms, a legal right connected to its bioactive function is declared insofar as exclusive rights in the form of patents are claimed by the developer. In essence, modern genetic technology employed in bioprospecting transcends and challenges the conventional divisions of processes as either organic or synthetic. Since in bioprospecting it is increasingly difficult to ascertain whether an element or process is natural, it is similarly difficult to determine whether if falls within obligations of international law which applies to natural (but not artificial) elements and processes.

A.4. Purpose and research question

This study aims to investigate whether public international law manages to function as a coherent system in the case of deep-sea bioprospecting, where rules in three regimes provide seemingly inconsistent obligations for states. This study will thus examine international law in the context of bioprospecting of deep-sea genetic resources. Both sides of this relationship will be investigated. It is not merely an investigation of rules in international law relevant for deep-sea bioprospecting, but also an examination of what conclusions can be drawn on the nature and function of international law in light of how the latter relates to deep-sea bioprospecting.

The aim is addressed by the means of the following research question:

Could apparent inconsistencies between the three regimes be dissolved under treaty law rules on application and interpretation?

In order to reply to the principal research question, this study is divided into several themes:

At its core, this is an enquiry into the ability of international law to handle new activities. In order to understand the challenges this represents for the law, a closer look at bioprospecting as an activity is required. Part B therefore reviews what distinguishes bioprospecting for deep-sea genetic resources as an activity. It describes how bioprospecting has developed, as well as the technology and different phases that are involved, from the sampling of genetic resources originating in deep-sea organisms to product development.

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Particular emphasis is devoted to the role of the natural compound in these development chains as well as the interconnections of actors involved in different stages of bioprospecting processes. Deep-sea bioprospecting will be described as a complex activity while focusing primarily on the characteristics that need to be considered when assessing the relationship to international law. This presentation will serve as the basis for an examination in Part C of rules in public international law relevant to deep-sea bioprospecting, focusing on the United Nations Convention on the Law of the Sea, the Convention on Biological Diversity and the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights. This will illustrate how the rules of these treaties provide different and seemingly inconsistent obligations to deep-sea bioprospecting.

This examination in turn serves as the starting point for Part D, which examines why the investigated treaties raise seemingly incoherent obligations for deep-sea bioprospecting, despite the fact that they are all part of public international law. Part D discusses how the substantive differences across the three treaties relate to their origin in different sub-fields or regimes of public international law with distinctively dissimilar perspectives on the appropriation of genetic resources. It is further investigated how these differences reflect underlying ideological divergences across these three regimes, as well as a lack of consideration for the rules in other regimes during treaty drafting and negotiation.

Part E considers the consequences of the difference between rules applying to deep-sea bioprospecting across the investigated treaties. The apparent inconsistency between the applicable rules is more closely examined. It is discussed if the prima facie norm conflict can be resolved on the basis of the principles on treaty application and interpretation under the Vienna Convention on the Law of Treaties.20

Finally, Part F discusses what conclusions can be drawn based on the case of deep-sea bioprospecting in the context of the debate on the fragmentation of international law and the development of new rules.

20_{Vienna Convention on the Law of Treaties, adopted in Vienna, 23 May 1969, 1155 U.N.T.S.}

331, 8 ILM 679 (1969) [hereinafter the Vienna Convention].

Taken together, the study will thus firstly show how deep-sea bioprospecting has developed and is conducted, secondly explore the relevant rules in public international law for this activity, thirdly explain why different regimes have developed seemingly inconsistent rules, fourthly investigate if rules of treaty law are able to dissolve this inconsistency, and fifthly discuss the systemic implications.

A.5. Delimitation, material and method

This study can be regarded as an investigation into a new practical activity, what rules international law provides in relation to said activity and the reasons for and consequences of how rules of international law apply to this activity. It focuses on the relation between international law and bioprospecting based on genetic resources from marine organisms in the deep-sea areas of the oceans, beyond the jurisdiction of coastal states.

Bioprospecting is defined in this study as a process whereby commercially useful products are technologically derived, processed and developed based on the collection of marine genetic resources.21_{Rather than attempting to} encompass all applications of bioprospecting, the investigation is primarily concerned with bioprospecting that aims to develop products in the pharmaceutical sector, which not only makes up the largest type of such operations, but also most clearly highlights the central legal issues involved. This does not necessarily render the investigation irrelevant to other types of bioprospecting. Indeed, many of the challenges involved are common across sectors. Similarly, much of the discussion on bioprospecting as a process and activity may also be relevant to bioprospecting in coastal waters, although the discussion on applicable rules principally is concerned with marine areas beyond national jurisdiction.

The study is based on a review in Part B of what characterizes marine bioprospecting; how it has developed, what distinguishes it from other uses of marine resources, conventional scientific research and synthetic approaches, as well as the role of the natural compound and technology in bioprospecting processes.

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The review will thus encompass the full cycle of bioprospecting development and not be confined to the physical sampling of bioresources in the natural environment and the role of the natural compound. Apart from the collection of marine genetic resources, this process includes technological derivation, processing and development of commercially useful products.22_Deep-sea bioprospecting is thus approached not as an isolated activity, but as a complex process, which may appear considerably different across cases. In addition to examining the bioprospecting process and its development, this review will thus investigate how modern genetic technology has transformed bioprospecting. In addition, the intricate relationships between different actors involved in bioprospecting processes will be particularly highlighted. Commonly, bioprospecting involves a multitude of actors, which may come from private enterprise as well as governmental and academic institutions. As regards material, this review uses the work of the OECD on marine biotechnology as a starting point.23_{In addition, it connects to an inventory of} studies on the topic.

The review in Part B serves as the basis for an examination in Part C of the obligations under international law relevant for deep-sea bioprospecting which apply to states. This reflects the emphasis of this study on public international law, understood in a conventional sense as the body of legal norms that governs the relations between states and other subjects of international law.24_However, not all norms of international law of potential relevance for deep-sea bioprospecting are considered. The material scope has been limited to three regimes of public international law, and in each respective regime a strong emphasis is put on one treaty. Even if also other regimes of international law contain rules relevant (although more remotely) for deep-sea bioprospecting, the law of the sea, international environmental law and international trade (or

23_{More specifically, the review is based on the work of The OECD Working Party on}

Biotechnology (WPB) and the Working Party on Biotechnology, Nanotechnology, and

Converging Technologies (BNCT). See, in particular, OECD, MARINE BIOTECHNOLOGY:

ENABLING SOLUTIONS FOR OCEAN PRODUCTIVITY AND SUSTAINABILITY § No. 43 (OECD

Publishing. 2013); OECD, MARINE BIOTECHNOLOGY DEFINITIONS, INFRASTRUCTURES AND

DIRECTIONS FOR INNOVATION (2017).

24_I_AN_B_ROWNLIE_,_P_{RINCIPLES OF}_P_UBLIC_I_NTERNATIONAL_L_AW_{(Oxford : Oxford University Press}

6. ed. ed. 2003); JAN KLABBERS,INTERNATIONAL LAW (Cambridge University Press. 2017).

WTO) law have been selected because treaties of all these regimes contain obligations which concern the appropriation of deep-sea genetic resources.25 Accordingly, domestic regulation and private law rules will only be indirect references in this study, as will patent data relating to marine bioprospecting. To further curtail the scope, as the result of the geographical limitation to activities in the deep sea, the focus is limited to rules applying in these marine areas. The term “deep seas” refers to the marine areas considered beyond national jurisdiction in international law, where the water column is referred to as the high seas and the seafloor and underlying sediments are referred to as the Area.26_{In line with the broad approach to bioprospecting as an activity,} however, the full physical process of bioprospecting would not have to be carried out in these areas, as it rarely is in practice. Rather, the defining criterion for this investigation is that the genetic material originates in the deep seas.

Both the investigation of rules relevant for deep-sea bioprospecting in Part C and the discussion in Part E of how treaty law relates to potential inconsistencies across those rules are essentially investigations of legal norms. In line with the positivist approach used in these central parts of the study, the primary materials are legal sources and treaties in particular. Customary norms and case law are also investigated to a lesser degree.27_{The three investigated} treaties providing rules directly relevant for deep-sea bioprospecting comprise the central material in Part C.

25_{Deep-sea bioprospecting could also be investigated from the perspective of for instance}

international criminal law based on the notion of deep-sea bioprospecting as unlawful, in connection to enforcement jurisdiction under the law of the sea. Similarly, provisions on benefit sharing relating to genetic resources are connected to international development law. Deep-sea sampling may also interfere with international rules of (underwater) cultural heritage or international labor law.

26_{See Article 86 and 1 of UNCLOS. In Article 86, the high seas are defined negatively, ‘all parts}

of the sea that are not included in the exclusive economic zone, in the territorial sea or in the internal waters of a State, or in the archipelagic waters of an archipelagic State.’ In Article 1, “the Area” is defined as “the seabed and ocean floor and subsoil thereof, beyond the limits of

national jurisdiction.”

27_{As similarly will be discussed in the next section, this is in line with the positivist sources}

doctrine, often considered to be reflected in Article 38(1) of the ICJ Statute which instructs the ICJ what material ought to apply in disputes in accordance with international law. Statute of the International Court of Justice, United Nations 18 April 1946, 33 U.N.T.S. 993 [hereinafter ICJ Statute].

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In Part E, the rules on treaty interpretation and application in the Vienna Convention on the Law of Treaties are used as a central analytical reference point.

Primarily concerned with the reasons for differences across the rules of different regimes, the investigation in Part D is based on secondary sources, such as travaux préparatoires, rather than treaty texts. Different perspectives and material are thus used to address the research question. This is also reflected in the theoretical approaches used in the analysis, as will be discussed in the next section.

A.6. Fragmentation as a theoretical reference point

As the result of the increasing division of public international law into different regimes, concerns started to become widespread at the end of the 1990s that specialized treaties, courts and institutions would “develop greater variations

in their determination of general international law.”28_{There was a fear that}

this increasing specialization would result in systemic inconsistencies not only in the incoherent practice of different tribunals but also in the development of conflicting norms across treaties. It was considered that this development would risk harming the coherence of public international law.29

The debate on fragmentation initially focused on understanding, conceptualizing and evaluating fragmentation and later began to concentrate more on developing principles and procedures for coordinating and harmonizing, i.e. solving and preventing the unwanted consequences of fragmentation in order to preserve the integrity of the system.30_{Largely, the} observers involved in the discussion can be divided into two views.

28_{Jonathan I. Charney, Is international law threatened by multiple international tribunals? § 271}

(Springer. 1999).

29_{Fragmentation of International Law: Difficulties Arising from the Diversification and}

Expansion of International Law - Report of the Study Group of the International Law Commission. No. A/CN.4/L.682(2006).

30_{As summarized by Peters, Anne Peters, The refinement of international law: From}

fragmentation to regime interaction and politicization, 15 INTERNATIONAL JOURNAL OF

CONSTITUTIONAL LAW (2017), at 674.

A fragmented view, taken to its extreme, would suggest that international law is developing into several different systems, all of which are based on different logics and unable to cooperate across regime boundaries. The fragmented view is often contrasted with the systemic view, which would hold that international law, despite recent developments, remains a unitary legal system, composed of interconnected rules and principles.

In analyzing the concept, multiple causes have been referenced as contributing to fragmentation. On the functional side, three patterns of explanation are often referred to.

Firstly, it is claimed, such a development is essentially built into the decentralized structure that is international law.

Secondly, the concept is also connected to – and is a consequence of – arrangements on the domestic side: Different issue areas are divided between ministries and branches of government which are likely to take different positions in treaty negotiations. Even in efficient administrations, joint preparation rarely manages to counteract this problem.31

Thirdly, it has been stressed that fragmentation is a response to globalization. Global challenges have increased the demand for more international and more specific regulation.32_{On the political side, institutionalists have depicted} fragmentation as the result of a deliberate agenda of powerful states. According to this conception, the bargaining power of weaker states is reduced by fragmentation, since only states with greater “agenda-setting power” can create new regimes which better suit their interests.33_{Fragmentation has also been} divided into different types. As discussed by Peters, two relevant facets seem to be institutional fragmentation (different treaties, organizations, bodies, courts, etc.) and ideational fragmentation (different objectives and values).34

31_{Margaret A. Young, The Productive Friction Between Regimes, in R}_EGIME_I_{NTERACTION IN}

INTERNATIONAL LAW -FACING FRAGMENTATION (Margaret A. Young ed. 2012), at 1. Birnie,

Boyle and Redgwell has highlighted this lack of communication and consultation in the relation

between TRIPS and the CBD, which were negotiated at the same time, see PATRICIA W.BIRNIE,

et al.,INTERNATIONAL LAW AND THE ENVIRONMENT (Oxford University Press 3 ed. 2009), at 802.

32_{Peters, International Journal of Constitutional Law (2017), at 674.}

33_{Eyal Benvenisti & George W. Downs, The Empire's New Clothes: Political Economy and the}

Fragmentation of International Law, 60 STANFORD LAW REVIEW 595 (2007).

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How, then, does international law address issues of fragmentation? From the supporters of the systemic position there are mechanisms to prevent and to resolve inconsistencies resulting from fragmentation, embodied in the fundamental rules for treaty application and interpretation, as codified in Part III of the Vienna Convention on the Law of Treaties.35

Firstly, there is a conflict-solving element in the rules on application of

treaties, foremost expressed in Article 30, which regulates the application of

successive treaties relating to the same subject matter. As will be further explored, this provision establishes alternative problem-solving models to resort to in cases where several treaty norms overlap. For the purposes of this study, paragraph 2 of Article 30, which establishes that priority should be decided according to so-called conflict clauses of the respective agreements, is particularly relevant.

The rule indicates that preference should be given to treaty A in cases where treaty B, containing an overlapping norm, specifies that it is subject to, or not to be considered as incompatible with, treaty A. The rule in Article 30 thus makes clear that conflict clauses, provisions clearly articulating the relationship to other treaties, should be guiding in deciding what obligation applies in cases of norm conflict. This study will examine to what extent the investigated treaties contain provisions which can be regarded as such conflict clauses, and what material consequences they would yield under the rules for treaty application. As an alternative to the application of treaty conflict, Article 30 provides for application of lex posterior, a model whose consequences similarly will be evaluated in the case of deep-sea bioprospecting.

35_{Joost Pauwelyn, Bridging fragmentation and unity: international law as a universe of}

inter-connected islands, 25 MICHIGAN JOURNAL OF INTERNATIONAL LAW (2004); Ralf Michaels &

Joost Pauwelyn, Conflict of norms or conflict of laws? Different techniques in the fragmentation

of public international law, 22 DUKE JOURNAL OF COMPARATIVE &INTERNATIONAL LAW

(2012);RÜDIGER WOLFRUM &NELE MATZ,CONFLICTS IN INTERNATIONAL ENVIRONMENTAL LAW

(Springer. 2003).

Secondly, issues of potential inconsistencies across treaties may be approached based on the rules on treaty interpretation in Articles 31–33 of the Vienna Convention. Whereas the approach based on the rules on application attempts to resolve apparent conflicts between norms by establishing priority or hierarchies between the norms involved, approaching the matter from the perspective of interpretation implies considering if the seemingly inconsistent norms can be interpreted so that conflict is prevented. In the debate on fragmentation, the interpretation perspective has particularly focused on Article 31(3)(c), commonly referred to as the Principle of systematic

integration.

The rule, which provides instruction for treaty interpretation, requires the interpreter to take into account “any relevant rules of international law

applicable in the relations between the parties.” The rule essentially requires

any interpreter of international law to strive for coherence.36_{According to the} International Law Commission Study Group on fragmentation, this does not merely represent a possible way to interpret potentially conflicting obligations; rather, it is an obligation to interpret provisions of international law so as to preserve the coherence of the system.37_{The basic presumption of the principle} of systemic interpretation is that all treaty provisions set up rights and obligations that exist alongside rights and obligations established by other treaty provisions and rules of customary international law. None of such rights or obligations has any intrinsic priority against the others. The question of their relationship can only be approached through a process of reasoning that makes them appear as parts of some coherent and meaningful whole.38

36_{For an extensive analysis on the principle of systemic integration, see Campbell McLachlan,}

The Principle Of Systemic Integration And Article 31(3)(C) Of The Vienna Convention, 54

INTERNATIONAL AND COMPARATIVE LAW QUARTERLY (2005).

37_{Fragmentation of International Law: Difficulties Arising from the Diversification and}

Expansion of International Law - Draft conclusions of the work of the Study Group Finalized by Martti Koskenniemi. No. A/CN.4/L.682/Add.1(2006), para. 43, at 15.

38_{As expressed by Matz-Lück, “international law, e.g. a partial overlap of subject matters or}

common points of reference, and legal interrelation, e.g. rules on interpretation like Article 31(3)(c) VCLT, may lead to the consideration of norms which were created by one regime by the institutions of another. In particular the interpretation of treaties either by the parties or adjudicatory bodies offers the opportunity to specify the meaning of treaty norms by referring to other international rules and regulations, i.e. ‘extrinsic norms’. The consideration of such norms as normative guidance in the process of interpretation raises a variety of questions concerning the reasons, the legal foundations and limits, the competent actors, the results, legitimacy, and benefits and disadvantages.” Nele Matz-Lück, Norm Interpretation across

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As expressed by Koskenniemi in the report of the fragmentation study group, the provision operates like a “master key” to the house of international law. In case there is a systemic problem – an inconsistency, a conflict, an overlap between two or more norms – and no other interpretative means provides a resolution, then “recourse may always be had to that article in order to proceed

in a reasoned way.”39_{Under this understanding of the principle of systematic}

integration, it appears that conflicting norms can be stretched considerably. Accordingly, the ILC Study Group Report prognosticated that systematic integration would ensure coherence of the system of public international law, despite regime proliferation and differences. As already stated, it is noteworthy that it drew these conclusions regardless of having merely anecdotally tested the suggestion in practical cases. The fragmentation debate has generally paid less attention to the relevance of other elements of treaty interpretation rules in addressing potential inconsistencies. As will be further discussed, other elements of the Vienna Convention treaty interpretation rules provide obligations, which essentially set limits on how far interpretations can stretch the meaning of terms, relating to linguistic elements, as well as context and purposes of the relevant treaties.

In this study the possibility for dissolving apparent inconsistencies between norms relating to deep-sea bioprospecting will be discussed from the viewpoint of the rules on application and interpretation, including systemic integration. As previously mentioned, this case study principally aims to establish what rules apply to this specific activity. However, it can also be seen as a practical test (albeit a limited one) of the systemic qualities of international law, which may provide new perspectives on the concept of fragmentation.

International Regimes: Competences and Legitimacy, in REGIME INTERACTION IN

INTERNATIONAL LAW -FACING FRAGMENTATION (Margaret A. Young ed. 2012).

39_{Koskenniemi, Fragmentation of International Law - Report of the Study Group of the}

International Law Commission. 2006., at 211.

B. The marine bioprospecting process

B.1. Marine bioprospecting – a multifold activity

There is no generally agreed definition of marine bioprospecting in international law. In domestic legislation, the term is occasionally used, but varies significantly in meaning.40_{In this study, the concept is defined as a}

process whereby commercially useful products are technologically derived, processed and developed based on the collection of marine genetic resources.

Other definitions have been suggested in the literature, as well as by international organizations. For instance, bioprospecting has been described in some previous academic work as a process whereby commercially useful products are derived from living resources.41_{A considerable weakness in this} description is that it would include activities which, according to ordinary language, would be considered as other activities. For instance, it can be claimed that the conventional fisheries industry derives commercially valuable products from living resources simply by fileting, packaging and commercially distributing fish. Accordingly, in order to distinguish bioprospecting from other uses of marine resources, the technological element which is central to bioprospecting must be considered.

The OECD has defined marine bioprospecting as “the application of science and technology to living organisms from marine resources, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services.”42_{This definition captures many} of the central elements of the definition used here (albeit in an overtly technical language); in particular, it foregrounds elements of the technological process, which were lacking in the previous example. Yet, like the previous example, the OECD definition suffers from a lack of precision. Foremost, it contains no reference to commercial motivations or product development.

40_{In some domestic legislations relating to access and benefit-sharing obligations bioprospecting}

has been defined.

41_{Joanna Mossop, Marine Bioprospecting, in T}_HE_O_XFORD_H_{ANDBOOK OF THE}_L_{AW OF THE}_S_EA

(Donald Rothwell, et al. eds., 2015).

42_{OECD, Marine Biotechnology Definitions, Infrastructures and Directions for Innovation}

Bioprospecting and Deep-Sea Genetic Resources in a Fragmenting International Law